AccessGUDID - DEVICE: NAR (10842209131515)

GUDID

Device Identifier (DI) Information

Brand Name: NAR
Version or Model: 20-0022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-0022
Company Name: NORTH AMERICAN RESCUE, LLC

Primary DI Number: 10842209131515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 832426782 *Terms of Use

Device Description: Eye Magnet Curette - 10 count.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46718	Eye magnet, non-powered	A non-electric hand-held instrument designed to generate a magnetic field intended to locate and remove metallic foreign bodies [typically those containing iron (Fe) or steel] from eye tissue; it may include a wire loop at one end for mechanical extraction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HPN	Magnet, Permanent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a1db584-a983-472d-ad9e-06744551c53c
Public Version Date: June 18, 2024
Public Version Number: 1
DI Record Publish Date: June 10, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00842209131518 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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